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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 089361

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NDA 089361 describes DICYCLOMINE HYDROCHLORIDE, which is a drug marketed by Annora Pharma, Aurobindo Pharma Usa, Corepharma, Lannett, Pioneer Pharms, Prinston Inc, Rising, Sun Pharm Industries, Twi Pharms, Watson Labs, West Ward, Am Regent, Dr Reddys, Fosun Pharma, Fresenius Kabi Usa, Hikma, Nexus, Praxgen Pharms, Renew Pharms, Slate Run Pharma, Somerset Theraps Llc, Alpharma Us Pharms, Novitium Pharma, Ph Health, Bionpharma, Hikma Pharms, and Rubicon Research, and is included in forty-two NDAs. It is available from fifty suppliers. Additional details are available on the DICYCLOMINE HYDROCHLORIDE profile page.

The generic ingredient in DICYCLOMINE HYDROCHLORIDE is dicyclomine hydrochloride. There are four drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.

Summary for 089361

Tradename:	DICYCLOMINE HYDROCHLORIDE
Applicant:	Pioneer Pharms
Ingredient:	dicyclomine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 089361

Muscarinic Antagonists
Parasympatholytics

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Jan 10, 1989	TE:		RLD:	No

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